Amprion Unveils Next-Generation SAAmplify™ Biomarker Panels to Aid in Diagnosis of Neurodegenerative Disorders at AAIC 2024
2024年7月26日 - 8:00PM
ビジネスワイヤ(英語)
New comprehensive biomarker panels equip
physicians with clinically actionable insights for earlier, more
accurate diagnosis
Amprion, a global leader advancing diagnosis of
neurodegenerative disorders through seed amplification testing, is
launching a new line of cerebrospinal fluid (CSF) biomarker panels:
SAAmplify. Physicians and their patients will now have access to
the most comprehensive set of biomarkers available to aid in the
diagnosis of Parkinson’s disease, Lewy body dementia, and
Alzheimer’s disease with the Lewy body variant.
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Amprion Unveils Next-Generation
SAAmplify™ Biomarker Panels to Aid in Diagnosis of
Neurodegenerative Disorders (Graphic: Business Wire)
Each panel leverages Amprion’s flagship seed amplification assay
(SAA) that identifies misfolded ɑ-synuclein aggregates in CSF.
Amprion’s SAA, originally named the SYNTap® Biomarker CSF test, has
made the detection of misfolded ɑ-synuclein aggregates possible
with autopsy-confirmed accuracy. The only ɑ-synuclein assay of its
kind, SAA is already advancing the field, leading to a proposed new
definition of the subgroup of neurodegenerative diseases
characterized by abnormal accumulation of alpha-synuclein protein
in the nervous system as synucleinopathies.
Since its initial launch in 2022, Amprion has made notable
enhancements to the assay, further improving its sensitivity and
reducing assay time. This next-generation assay will be made
available under the SAAmplify brand in the second half of 2024.
Additional common biomarkers, such as total Tau, pTau 181, Aβ1-42,
Aβ1-40, and NfL, are combined with SAAmplify-ɑSYN in various
configurations to create the new panels.
“This level of accuracy is like having a window into the brain
itself,” said Russell Lebovitz, MD, PhD, CEO and co-founder of
Amprion. “With these new panels, clinicians will have the
biological insights to develop a diagnosis for prodromal and
symptomatic patients alike, which has never before been possible.
Patients navigating a potential neurodegenerative disorder
diagnosis are often met with unclear answers. We’re hoping to bring
some much-needed clarity to patients and their loved ones with this
novel technology.”
Recently published studies in The Lancet Neurology, Alzheimer’s
and Dementia, and other leading journals continue to validate the
technology, demonstrating the high sensitivity and specificity of
Amprion’s SAA for detecting ɑ-synuclein aggregates in CSF—all of
which is also confirmed by autopsy. To review these findings, visit
www.ampriondx.com/promo.
“Accurate confirmation is critical to support clinical diagnosis
of disorders with Lewy-body pathology or copathology, as it allows
clinicians to confidently develop a differential diagnosis based on
each patient’s biology," said Marwan Sabbagh, MD, neurologist at
Barrow Neurological Institute and scientific advisor for Amprion.
“Symptoms can confound diagnosis, leaving patients and their
caregivers without the necessary insights to optimally or
effectively manage their condition."
Amprion will premiere the new SAAmplify test panels at the
upcoming Alzheimer’s Association International Conference (AAIC)
2024, the largest international meeting dedicated to advancing
dementia science and clinical practice. The Amprion team will be
meeting with clinicians, partners and media (booth 1125). For
inquiries, email Info@AmprionDx.com or visit www.ampriondx.com to
learn more.
About SAAmplify-ɑSYN (formerly SYNTap®)
Amprion's SAAmplify-ɑSYN Biomarker Test is a
first-in-class-qualitative Laboratory Developed Test (LDT) and the
only seed amplification assay available to aid the diagnosis of
synucleinopathies such as Parkinson's disease (PD), Lewy body
dementia (LBD/DLB), and Alzheimer's disease (AD) with Lewy body
variant. The U.S. Food and Drug Administration (FDA) granted
Amprion a Breakthrough Device Designation in 2019 for use of the
test as an aid in the diagnosis of PD. SYNTap became commercially
available in 2021.
About Amprion
Amprion is a global leader advancing diagnosis of
neurodegenerative disorders through seed amplification testing. As
the global population ages, Amprion aims to accelerate precision
medicine for neurodegenerative disorders by helping biopharma
partners identify new drug candidates and underlying pathologies.
The amplification testing methodology was originally developed by
Claudio Soto, PhD, Amprion's Co-Founder and Professor at The
University of Texas Health Science Center at Houston and has been
further enhanced and validated by Amprion's in-house scientific
team. Amprion currently holds multiple U.S. and International
patents for SAA methodology and strives to launch more biomarker
tests to detect a wide range of early-stage neurodegenerative
disorders. For more information, visit
https://ampriondx.com/ or find us on LinkedIn.
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